Surgical string applicator for anastomosis surgery

ABSTRACT

A surgical string applicator for anastomosis surgery is provided. The surgical string applicator includes an elongate shaft; a string applying assembly including a pair of opposing jaws connected to the elongate shaft, each jaw having an opening at its distal end, one or more surgical strings housed in the jaws in a form of an open loop with one end of the surgical string at the distal end of one jaw and an opposing end of the surgical string at the distal end of the other jaw, and a string fastening mechanism adapted to engage and fasten the surgical string around a tubular organ; and a handle portion including control mechanisms adapted to open and close at least one of the jaws and to actuate the string fastening mechanism. Further provided is an intra-lumenal position guide to be used together with the surgical string applicator.

CROSS REFERENCE TO RELATED APPLICATION

This application is a division of patent application Ser. No. 15/351,987filed Nov. 15, 2016, which is a continuation of patent application Ser.No. 13/058,521 filed Feb. 10, 2011, now issued as U.S. Pat. No.9,526,502, which is a national phase of PCT application No.PCT/US2009/056411, filed Sep. 9, 2009, which is a continuation-in-partof patent application Ser. No. 12/283,152, filed Sep. 10, 2008, nowissued as U.S. Pat. No. 8,211,129. All parent patent applications arehereby incorporated by reference in their entireties.

FIELD OF THE INVENTION

The present invention relates to a surgical device and the method of usefor anastomosis surgery, particularly relates to a surgical stringapplicator for anastomosis surgery.

BACKGROUND OF THE INVENTION

Surgical anastomosis is to join together two hollow organs, usually torestore continuity after resection, or less commonly to bypass anunresectable disease process. Anastomosis is typically performed onblood vessels including arteries and veins, gastrointestinal tractincluding esophagus, stomach, small intestine, colon, rectum, bile ductsand pancreas, urinary tract including ureters, urinary bladder andurethra, and fallopian tubes.

Colorectal anastomosis surgery is one of the most commonly performedintestinal surgical anastomosis (“Surgical Treatment of Rectal Cancer”,Bleday R. et al, The ASCRS Textbook of Colon and Rectal Surgery, 2007,Springer, New York, page 413-436). Historically, laparotomies (opensurgery) are performed. During the surgical procedure, after dissectingthe colon from the rectum and resecting the diseased segment, such ascancerous tissue, from the colon, the two dissected open ends aremanually sutured together. This is a time-consuming and often verydifficult process. Particularly, when the diseased segment is located atthe extreme low end of the rectum, which is deep in the lowest part ofthe pelvis, it can be extremely difficult to manually access thedissecting site. Under such circumstances, the surgery has a higher riskof anastomotic leakage, which causes severe infectious complications andoften requires reoperation for an abscess, fistula, peritonitis, or apermanent colostomy (bringing the colon out through the abdominal wallso that waste can be collected in a bag rather than by evacuating stoolthrough the anus).

In the past few decades, linear and circular surgical staplers have beendeveloped and mechanically stapled methods are increasingly used incolorectal surgeries. The stapled colorectal anastomosis is faster andoften more convenient for the surgeon to operate. However, variouscomplications have been associated with stapled colorectal anastomosis.In the stapled colorectal anastomosis procedure, the linear and circularstapled areas overlap, which increases the risk of leakage at theinterface between the linearly stapled area and the circularly stapledarea. It has been reported in numerous publications that the instancesof colorectal strictures in stapled anastomosis are statistically higherthan in sutured colorectal anastomosis (“Stapled anastomosis aftercolorectal resection for benign and malignant disease”, Raidoo, S N etal, S Afr Med J. 1984, 66(21):819-21; “Handsewn vs. stapled anastomosisin colon and rectal surgery: a meta-analysis”, MacRae, H M et al, DisColon Rectum. 1998, 41(2):180-9; “Results of reoperations in colorectalanastomotic strictures”, Schlegel R D et al, Dis Colon Rectum. 2001,44(10): 1464-8; “Anastomotic dehiscence in colorectal surgery, Analysisof 1290 patients”, Pronio, A et al, Chir Ital. 2007, 59(5): 599-609.)

More recently, laparoscopic colorectal anastomosis surgery method hasbeen developed. With the laparoscopic method, a small cut is made on thelower abdomen, an endoscopic linear cutting stapler is inserted intopelvic cavity to transect the rectum, and a circular stapler issubsequently used to perform a colorectal colocolic, ileorectal, orileoanal anastomosis. Laparoscopic colorectal anastomotic procedureshave the advantages of a small wound, less trauma, and an overall fasterpatient recovery. However, the inherent problems from the stapledcolorectal anastomosis remain in laparoscopic stapled anastomosisprocedures. Furthermore, in laparoscopic colorectal anastomosisprocedures, the head of the linear stapler can only be operated in arange from 0° to about 45° from the shaft. When the site for transectionis in the distal rectum, it can be very difficult to transect the rectumwith the linear cutting stapler. Typically, two or three sequentialprogressive stapling and cutting cartridges are required to transect thelower rectum. Each cut requires removing the stapler from the abdominalcavity and loading a new cartridge to the head of the stapler. Thismultifire approach is not only time consuming, but also a higher risk ofcomplications and anastomotic leakage.

Therefore, there exists a strong need for improved tools and surgicalmethods to reduce the risks associated with existing sutured andstapling methods for anastomosis to improve operability under difficultconditions, to improve quality and outcome of the anastomosis and toreduce the cost of an anastomosis surgery.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a surgical stringapplicator for anastomosis surgery. In one embodiment, the surgicalstring applicator comprises an elongate shaft having proximal and distalends; a string applying assembly comprising a first and a secondopposing jaws connected to the distal end of the shaft, at least one ofthe jaws having a curved shape with a concave inner side and having oneor more grooves along an inner surface of the curved jaw, each of thegrooves configured to receive therein at least a portion of a surgicalstring to be applied, and a string fastening mechanism adapted to engageand fasten the surgical string; and a handle portion connected to theproximal end of the shaft; the handle portion including controlmechanisms adapted to open and close at least one of the jaws, and toactuate the string fastening mechanism. The surgical string applicatorfurther includes a blade disposed within one of the jaws, adapted todissect tissue fastened by the surgical strings.

In one embodiment, the proximal ends of the first and second jaws areconnected to the distal end of the elongated shaft, and at least one ofthe jaws pivots at the proximal end thereof. In another embodiment, aproximal end of one of the jaws is connected to the elongated shaft anddistal ends of the first and second jaws are pivotally connected to eachother.

In one embodiment, the surgical string applicator includes two parallelgrooves at least one of the jaws with a predetermined distancetherebetween, and further comprises two surgical strings, each disposedwithin one of the grooves with a tail thereof disposed in a distal endof one of the jaws and a portion thereof disposed in a distal end ofopposing jaws.

In one embodiment, the string fastening mechanism comprises a tiegripping member disposed within one of the jaws adapted to grip a tailof the surgical string, and a tightening mechanism which includes adriving mechanism to pull the tail of the surgical string. In a furtherembodiment, the surgical string applicator further includes a pair ofhead-tail connected zip-ties disposed within one of the grooves of thejaws, wherein a first zip-tie has a tail thereof disposed at a distalend of one of the jaws, and a second zip-tie has a head thereof disposedat a distal end of opposing jaw and has a tail thereof passing throughand locked with a head of the first zip-tie, and coupled with thetightening mechanism for fastening the loop formed by the two head-tailconnected zip-ties.

In one embodiment, one end of one of the jaws includes an openingadapted to receive a tail portion of a surgical string. The opposingends of the jaws are so configured that when the jaws move from an openposition to a close position, a tail of the surgical string disposed atone of the opposing ends of one of the jaws is caused to enter into theopening disposed at the opposing end of opposing jaw. Moreover, in afurther embodiment, the string applying assembly further comprises a tieadvancing mechanism disposed within one of the jaws, adapted to advancethe tail portion of the surgical string for entering into the openingdisposed at an opposing end of opposing jaw.

In a further aspect, the present invention provides a surgical stringapplicator system for anastomosis surgery, which includes the surgicalstring applicator described above and an intra-lumenal position guide.The intra-lumenal position guide comprises a guide section having adistal end connected to a lead member, and a proximal end detachablyconnected to a proximal handle member. The guide section includes acylindrical body and multiple parallel grooves disposedcircumferentially therearound. The intra-lumenal position guide can beplaced into a tubular organ first, and the zip-ties can be fastened bythe surgical string applicator around the guide section. The guidesection can be cut by a surgical blade, and can also be perforatedlongitudinally by a circular stapler, which assists central alignment oftwo divided segments of a tubular organ.

In yet a further aspect, the present invention provides a method ofanastomosis surgery using surgical strings. In one embodiment, themethod comprises fastening a first and a second zip-tiescircumferentially around a tubular organ or a connecting region betweentwo tubular organs, with the first and second zip-ties beside each otherwith a space therebetween sufficient for dissecting the tubular organ orthe connecting region by a cutting edge; dissecting the tubular organ orthe connecting region at the space between the first and secondzip-ties, forming a first tubular portion with a first zip-tied end anda second tubular portion with a second zip-tied end; resecting a targetsegment from the second tubular portion, forming a resected end; placingone head member of a circular stapling device through resected end intothe second tubular portion with a locking shaft of the one head memberprotruding from the resected end, and centrally fastening the resectedend around the locking shaft of the one head member to form a centrallyfastened resected end; placing another head member of the circularstapling device into the first tubular portion against the firstzip-tied end, with a locking shaft of the another head member protrudingfrom the first zip-tied end adjacent to the first zip-tie; joining thelocking shafts and pulling the head members of the circular staplingdevice together with the first zip-tied end and centrally fastenedresected end against each other; stapling the first tubular portion andthe second tubular portion together, with staples encircling the firstzip-tied end and the centrally fastened resected end; and cuttingtissues encircled by the staples and removing cut tissues and thezip-tie to recreate a tubular path.

In a specific embodiment, the present invention is directed to a methodof colorectal anastomosis surgery using surgical strings such aszip-ties. The method comprises fastening a first and a second zip-tiescircumferentially around rectum or sigmoid colon, with the first andsecond zip-ties beside each other with a space therebetween sufficientfor insertion of a cutting edge; dissecting at the space between thefirst and second zip-ties, forming dissected rectum with a firstzip-tied end and dissected colon with a second zip-tied end; resecting atarget segment from the dissected colon, forming a resected end; placingone head member of the circular stapling device through the resected endinto the colon with a locking shaft of the one head member protrudingfrom the resected end, and centrally fastening the resected end aroundthe locking shaft of the one head member to form a centrally fastenedresected end; placing another head member of a circular stapling deviceinto the dissected rectum against the first zip-tied end, with a lockingshaft of the another head member protruding from the first zip-tied endadjacent to the first zip-tie; joining the locking shafts and pullingthe head members of the circular stapling device together with the firstzip-tied end and the centrally fastened resected end against each other;stapling the rectum and the colon together, with staples encircling thefirst zip-tied end and the centrally fastened resected end; and cuttingtissues encircled by the staples and removing cut tissues and thezip-tie to recreate a colorectal path.

The advantages of the present invention will become apparent from thefollowing description taken in conjunction with the accompanyingdrawings showing exemplary embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the rectosigmoid region of a patient exposed in anopen colorectal anastomosis surgery, with a clamp next to the dissectingsite on the lower part of the rectum prior to anastomosis.

FIG. 2 illustrates transecting the rectum using a linear cutting staplerin a double or a triple stapling open rectosigmoid resection surgery.

FIG. 3 illustrates resection of a target segment in the colon using alinear cutter.

FIG. 4 shows a circular stapler for colorectal anastomosis surgery. FIG.4A shows the anvil and the head of the circular stapler joined throughthe anvil shaft and the center rod of the head.

FIG. 5 illustrates after resection of the target segment, the anvil ofthe circular stapler is placed into the open proximal colon in a doubleor a triple stapling rectosigmoid resection surgery.

FIG. 6 illustrates the proximal colon containing the anvil is closedwith a linear stapler. FIG. 6A illustrates a small incision is made atthe midpoint of the stapled linear closure to retrieve the anvil shaftfor a triple stapled procedure.

FIG. 7 illustrates that the head of the circular stapler is transanallyplaced into the rectum, and the tip of the center rod is advanced toperforate the rectal linear staple line at its midpoint.

FIG. 8 illustrates that the anvil is closed against the stapling andcutting cartridge of the circular stapler. The colon is positioned sothat the two linear staple lines are at right angles to one another in across-like mode. FIG. 8A illustrates the interface region between therectum and the colon after the circular stapler is transanallyretrieved, showing the overlap between the two stapled linear closuresand stapled circular closure resulted from a triple staplingrectosigmoid resection procedure.

FIG. 9 illustrates the stapled linear closure of the rectum and suturedclosure of the colon during a double stapling rectosigmoid resectionprocedure, when the anvil shaft and center rod of the circular staplerare joined, prior to the anvil being closed against the cartridge of thehead.

FIG. 10 illustrates manual suturing of the dissected end of the rectumstump to apply a traditional open manual purse-belt.

FIGS. 11 and 11A show a zip-tie in one embodiment of the presentinvention in open and closed positions, wherein the gear rack isdisposed on the inner surface of the zip-tie.

FIG. 12 shows a zip-tie in a further embodiment of the present inventionin a closed position, wherein the inner surface of the zip-tie is smoothand the gear rack is disposed on the outer surface.

FIGS. 13 and 13A show a zip-tie in another embodiment of the presentinvention in open and closed positions, respectively, wherein the innersurface of the zip-tie includes a plurality of protuberances at the headportion and the gear rack is disposed on the outer surface.

FIG. 14 shows an illustrative perspective view of a zip-tie applicatorin one embodiment of the present invention. FIG. 14A shows an enlargedperspective view of the zip-tie tensioner of the applicator shown inFIG. 14.

FIG. 15 illustrates the use of the zip-tie applicator shown in FIG. 14in an open rectosigmoid resection procedure, with the zip-tie tensionerof the applicator wrapping around the rectum at the dissecting site tofasten the rectum circumferentially using two zip-ties carried withinthe tensioner.

FIG. 16 illustrates two zip-tied ends after transecting the rectum, andresection of a target segment in the colon.

FIG. 17 illustrates that the head of the circular stapler carrying thestapling and cutting cartridge is transanally inserted into the rectum,and the tip of the center rod is advanced to perforate zip-tied closureadjacent to the zip-tie. FIG. 17A illustrates that a guide wire isintroduced into the rectum first with the distal end thereof remainingoutside of the anus and the proximal end thereof in the abdomen cavity,before the distal end of the guide wire is fastened to the center rod ofthe circular stapler for guiding the center rod to perforate thezip-tied closure adjacent to the zip tie.

FIG. 18 illustrates the interface region between the rectum and thecolon after the circular stapler is removed, showing a smooth circularclosure between the rectum and the colon.

FIG. 19 illustrates the zip-tied transected end of the colon taken outfrom the small incision on the abdomen before resection of the targetregion.

FIG. 20 illustrates the zip-tied resected end of the colon with theanvil placed with the proximal colon and the anvil shaft remainingoutside of the colon, prior to placing the colon back into the pelviscavity.

FIG. 21 is a side view of a surgical string applicator in one embodimentof the present invention. FIG. 21A is a side view of the surgical stringapplicator shown in FIG. 21, with the jaws opened.

FIG. 22 is a side view of a surgical string applicator in a furtherembodiment of the present invention. FIG. 22A is a side view of thesurgical string applicator shown in FIG. 22, with one jaw opened.

FIG. 23 is a front perspective view of the pair of jaws of the surgicalstring applicator shown in FIG. 21, with the jaws opened. FIG. 23A showsa cross section of the lower jaw, along line A-A in FIG. 23, with twozip-ties placed within the grooves. FIG. 23B is an enlarged view of thedistal end of the lower jaw.

FIG. 24 is an illustrative top view showing a chuck of the tie grippingmember in the channel underneath the grooves in the lower jaw shown inFIG. 23. FIG. 24A is a cross-sectional view of the chuck shown in FIG.24, taken along one passage of the chuck.

FIG. 25 is an illustrative side view of the jaws, showing the zip-tiesand the tie gripping member including the chuck and the belt within thejaws before the jaws are completely closed. FIGS. 25A and 25B areenlarged views of the distal ends of the two jaws in FIG. 25, showingthe distal ends of the jaws before and after complete closing of thejaws. FIG. 25C shows the zip-ties being fastened within the closed jawsshown in FIG. 25.

FIG. 26 is an illustrative view showing the relationship between twohead-tail connected zip-ties when they are placed into the grooves ofopened jaws (not shown) in one embodiment of the present invention.

FIG. 27 shows the loop formed between the two head-tail connectedzip-ties shown in FIG. 26 being fastened within the closed jaws.

FIG. 28 is a perspective view of a surgical string applicator in afurther embodiment of the present invention.

FIG. 29 is a side view of a surgical string applicator in anotherembodiment of the present invention, in which the curved jaws have anelliptical shape when they are closed, suitable for insertion into acannula, or trocar used in laparoscopic surgery. FIG. 29A is a partialside view of the surgical string applicator shown in FIG. 29, with oneof the curved jaws opened. FIG. 29B is a partial side view of a surgicalstring applicator in a further embodiment of the present invention,showing distally hinged jaws in a completely open position.

FIG. 30 is a perspective view of an intra-rectal guide in one embodimentof the present invention.

FIG. 31 is an exploded side view of the intra-rectal guide shown in FIG.30.

FIG. 31A is an enlarged side view of the guide section.

FIG. 32 is an illustrative view, showing the center rod of the head ofthe circular stapler perforating through the rear portion of the guidesection of the intra-rectal guide.

FIG. 33 is an illustrative view showing the zip-tied colon joined by theanvil to the zip-tied rectum, with the rear portion of the guide sectionof the intra-rectal guide remained around the center rod of the circularstapler.

It is noted that in the drawings like numerals refer to like components.

DETAILED DESCRIPTION OF THE INVENTION

In one embodiment, the present invention provides a method ofanastomosis surgery using zip-ties.

For the purpose of understanding and appreciating the differences of themethod of the present invention from, and the advantages over, the priorart methods, the existing stapled and sutured colorectal anastomosissurgery methods are briefly described first in reference to drawings.

FIG. 1 illustrates the rectosigmoid region of a patient exposed in anopen colorectal anastomosis surgery, with a clamp 70 clampingimmediately next to the dissecting site 2 between the rectum 20 and thecolon 30 in the lower pelvis cavity 10 behind the pubis 12.

In a double or a triple stapling open rectosigmoid resection procedure,a linear stapler 40 is used to close the rectum 20 and the colon 30 atthe dissecting site 2, as shown in FIG. 2. The linear stapler has a head42 which includes a disposable cartridge carrying staples. When thelinear stapler is activated, it staples the tissue with two double rowsof staples with a space therebetween. The dissecting site 2 is thentransected in the space between the two double rows of staples. This canbe performed manually by the surgeon using the superior edge of thestaples as a guide. Alternatively, the dissecting site 2 can bemechanically transected using a linear cutting stapler that has a linearblade disposed between the two rows of staples. When the linear cuttingstapler is activated, it staples the tissue with two parallel rows ofstaples first, and then dissects the tissue by the blade in the spacebetween the two rows of the staples.

As shown in FIG. 3, the dissection results in two free dissected ends,one dissected end 24 is a stapled linear closure 24 a of the rectum 20,and the other dissected end 34 is a stapled linear closure of the colon30. As further shown in FIG. 3, subsequently a target segment 35 in thecolon 30, which may include a tumor or other abnormalities, is resectedat a resecting site 36 by a linear cutter 76, which results in aresected end 38.

To rejoin the rectum and the colon after resection, a circular stapleris used. FIG. 4 illustrates a circular stapler 50 known in the art.Circular stapler 50 includes an elongated shank 52 with a handle 51 onone end and a cartridge 54 on the opposing end. As shown in FIG. 4A,cartridge 54 carries a plurality of staples arranged in a circle at thefront end 58 of the cartridge. Extending forward from cartridge 54 is acenter rod 56, which is herein also referred to as a locking shaft,adapted to interlock with an anvil shaft 66 (another locking shaft) of aremovable anvil 60. When center rod 56 is interlocked with anvil shaft66, anvil 60 can be pulled toward cartridge 54 until the surface 62 ofanvil 60 against the front end 58 of cartridge 54. Since anvil 60 andcartridge 54 are two head members of a circular stapling device, andherein they are also referred to as one head member and another headmember or vise versa.

As illustrated in FIG. 5, to rejoin the rectum and the colon usingcircular stapler 50, anvil 60 is placed into the lumen of the colon 30from the resected end 38. In the triple stapling colorectal anastomosisprocedure, the resected end 38 is closed by a linear stapler 40 a, whichforms a linear closure 38 a fastened by staples 49 as shown in FIGS. 6and 6A. Anvil shaft 66 is pulled out from the stapled linear closure 38a through a small incision 39 at about the midpoint of the linearclosure. Alternatively, in a double stapling colorectal anastomosisprocedure, the resected end 38 is sutured onto anvil shaft 66 (see FIG.9).

On the other hand, as shown in FIG. 7, the cartridge 54 is transanallyinserted into the rectum 20 and advanced to the extent that the frontend 58 of cartridge 54 is positioned against the stapled linear closure24 a, and then center rod 56 is advanced to perforate the linear stapleline about its midpoint. Center rod 56 and anvil shaft 66 are engagedand interlocked through a locking mechanism within (not shown). Then,anvil 60 is pulled toward the cartridge 54, along with the colon 30,until surface 62 of anvil 60 is against the front end 58 of cartridge54, as shown in FIG. 8. As shown, the stapled linear closure 24 a ofdissected end 24 is horizontal, and the colon 30 is positioned to havethe stapled linear closure 38 a of resected end 38 in a verticalorientation, so that the two linear staple lines are at right angles toone another. The circular stapler 50 is activated to fasten dissectedend 24 and resected end 38 together by placing a circular doublestaggered row of anastomosing staples, which results in a stapledcircular closure 8 between the rectum 20 and the colon 30. Then, acircular blade disposed within cartridge 54 cuts through the colon andthe rectum inside the double rows of staples, and the cartridge 54 istransanally removed together with anvil 60 and the cut tissues, whichresults in the recreated colorectal pathway, see FIG. 8A.

As shown in FIGS. 8 and 8A, in the triple stapling colorectalanastomosis procedure, the stapled circular closure 8 formed in thefinal step overlaps with the stapled linear closures 24 a and thestapled linear closure 38 a. The overlapped areas have higher risks ofleakage and the tissues in the overlapped areas tend to scar, which mayultimately lead to stricture of the recreated pathway.

FIG. 9 illustrates the stapled linear closure of the rectum and suturedclosure of the colon during a double stapling rectosigmoid resectionprocedure, when the anvil shaft and center rod of the circular staplerare joined, prior to the anvil being closed against the cartridge of thehead. As shown, in this procedure the resected end 38 is sutured ontoanvil shaft 66, therefore, there is no stapled linear closure at theresected end 38. However, in the subsequent step of circular stapling,the stapled circular closure formed still overlaps with the stapledlinear closure 24 a. Therefore, the same issues discussed above in thetriple stapling colorectal anastomosis procedure are present.

In an open rectosigmoid resection procedure using manual suture withoutlinear staplers, the colon 30 is dissected from the rectum 20 at thedissecting site 2 as shown in FIG. 1, by a linear cutter (not shown).The dissected end 24 is manually sutured by the surgeon using needle 72and suture belt 74 to close the rectal stump, as illustrated in FIG. 10.After resection of a target segment in the colon, a circular stapler isused to rejoin the rectum and the colon as described above. In thisprocedure, the resected end 38 is sutured onto anvil shaft 66, asdescribed above in the double stapling rectosigmoid resection procedure.The cartridge 54 of circular stapler 50 is transanally placed into therectum 20, and then the rectum 20 and the colon 30 are rejoined bycircular stapling, as described above. In the manual sewn procedure, nostapled linear closure is present and hence the overlaps between thestapled linear closure and the stapled circular closure are avoided.However, as can be appreciated from FIG. 10, when the dissecting site 2is located in the lower extreme of the pelvis cavity behind the pubis12, manually suturing the dissected end 24 can be very difficult, andsometimes, it can be impossible. Due to poor accessibility, quality ofsuturing can be poor, which increases the risks of leakage and surgicalcomplications.

The present invention overcomes the problems of existing surgicalprocedures by providing a method of zip-tying or zip-tied anastomosissurgery, which can be used for anastomosis surgery of various tubularorgans, including the connection region between two tubular organs.

In one embodiment, the method is a double zip-tied procedure, whichcomprises the following steps:

(a) fastening a first and a second zip-ties circumferentially around atubular organ or a connecting region between two tubular organs, withthe first and second zip-ties beside each other with a spacetherebetween sufficient for dissecting the tubular organ or theconnecting region by a cutting edge;

(b) dissecting the tubular organ or the connecting region at the spacebetween the first and second zip-ties, forming a first tubular portionwith a first zip-tied end and a second tubular portion with a secondzip-tied end;

(c) resecting a target segment from the second tubular portion, forminga resected end;

(d) placing one head member of a circular stapling device throughresected end into the second tubular portion with a locking shaft of theone head member protruding from the resected end, and centrallyfastening the resected end around the locking shaft of the one headmember to form a centrally fastened resected end;

(e) placing another head member of the circular stapling device into thefirst tubular portion against the first zip-tied end, with a lockingshaft of the another head member protruding from the first zip-tied endadjacent to the first zip-tie;

(f) joining the locking shafts and pulling the head members of thecircular stapling device together with the first zip-tied end andcentrally fastened resected end against each other;

(g) stapling the first tubular portion and the second tubular portiontogether, with staples encircling the first zip-tied end and thecentrally fastened resected end; and

(h) cutting tissues encircled by the staples and removing cut tissuesand the zip-tie to recreate a tubular path.

In a further embodiment, in step (f) fastening the resected end aroundthe locking shaft of one head member is achieved by fastening a thirdzip-tie circumferentially around the resected end onto the locking shaftof one head member of the circular stapling device. As can beappreciated, this provides a triple zip-tied procedure.

Alternatively, centrally fastening the resected end around the lockingshaft of the one head member is achieved by manually suturing theresected end around the locking shaft of the one head member of thecircular stapling device.

Herein, the term “tubular organ” includes, but is not limited to,arteries, veins, esophagus, bile ducts, small intestine, colon, sigmoidcolon, rectum, ureter, urethra, fallopian tube, and appendix. It shouldbe understood that the first tubular portion and the second tubularportion resulted from the dissection can belong to the same tubularorgan, or belong to two different tubular organs, depending on thelocation of the target segment and purpose of the surgery. For example,in a situation of a colon cancer patient with a tumor located in amiddle portion of the colon, the first tubular portion and the secondtubular portion are both a part of the colon, and the recreated tubularpath is within the colon itself. However, in another situation of acolon cancer patient with the tumor located in the sigmoid colon, whichis directly connected to the rectum, if the dissecting site 2 shown inFIG. 1 is at an upper portion of the rectum, the first tubular portioncan be the rectum stump, and after resecting sigmoid colon, theremaining second tubular portion is the colon.

Therefore, the recreated tubular path is between the rectum and thecolon. In some extreme situations, small intestine may be connected tothe rectum after resecting the colon.

Herein, the phrase “dissecting a tubular organ or a connecting regionbetween two tubular organs” refers to, in most cases, transecting thetubular organ or the connecting region, which cuts the tubular organ intransverse to its longitudinal axis. However, “dissecting a tubularorgan or a connecting region between two tubular organs” herein alsoincludes cutting the tubular organ in an angle deviating from thetransverse direction, which, sometimes, is required in an anastomosisprocedure. Surgically, this action has also been referred to as dividingtwo tubular portions.

The term “target segment” refers to a segment of the tubular organ, orthe connecting portion of two tubular organs, which is to be resected bythe anastomosis surgery. Typically, the target segment includes abnormaltissue or abnormal organ structures affected by clinical conditions suchas benign and malignant neoplasias of the digestive tract, unspecificinflammatory diseases of digestive tract such as ulcerative colitis andCrohn's disease, appendicitis, Meckel's diverticulitis, esophagusdiverticulitis, Barrett's disease, obesity with metabolic disturbances,esophagus hernia, bile tract lithiasis, ureter stricture, and urethrastricture. In colorectal anastomosis surgery, the target segmenttypically include abnormal tissue or abnormal organ structures affectedby conditions such as benign and malignant colorectal neoplasias,diverticular disease, megacolon, volvulus, ulcerative colitis, Crohn'sdisease, colorectal trauma, colorectal or pelvic endometriosis, Ischemiccolitis, and anorectal abscess. However, the target segment may benormal tissue and organ structure. For example, in surgical treatment offunctional diseases, modifying the bowel movement and producing chronicconstipation, such as in treatment of colic inertia, a selected normalsegment of the digestive tract needs to be resected.

Herein, the term “centrally fastening” refers to fastening the tubularorgan toward the center of the longitudinal axis of the tubular organ.In contrast, a linear stapler fastens a tubular organ linearly insubstantially transverse direction of the longitudinal axis of thetubular organ. The term “cutting edge” includes regular surgical blades,and a sharp edge, blade, or knife carried in surgical cutting devices.

FIGS. 11 and 11A show a zip-tie 80 in one embodiment of the presentinvention, in an open and a closed configuration, respectively.Structures and mechanisms of zip-ties are known in the art. In general,a zip-tie, also commonly called cable tie, has a head, an elongatedstrap body or belt portion, and a tail. As shown in one embodiment,zip-tie 80 includes a sturdy belt 82 with an integrated gear rack 84 onone surface of the belt, a head 86 on one end and a tail 88 on theopposing end. Head 86 is in a form of a small open case including apassage and a ratchet (not shown) disposed within the passage. Once thebelt with the gear rack has been pulled through case 86 and past theratchet, it is prevented from being pulled backward, and the resultingloop can only be pulled tighter in one direction. The dimensions of belt82 may vary depending on the type of anastomosis surgery or the diameterof the tubular organ. For example, for colorectal anastomosis surgery,belt 82 may have a length from about 5 cm to about 10 cm, a width fromabout 2 mm to about 5 mm, and a thickness from about 1 mm to about 4 mm.However, for artery anastomosis surgery, belt 82 may have asubstantially shorter length.

As shown in FIG. 11A, the gear rack 84 is disposed on the inner surface82 a of belt 82, defined in reference to the locked loop. The gear rackmay serve two functions. One function is a locking mechanism of thezip-tie as described above. Another function is to provide a texturedsurface inside the loop, which provides a certain level of friction orresistance between the tissue and the zip-tie to prevent potentialsliding of the zip-tie when it is applied onto the tissue. In analternative embodiment, zip-tie 80′ has the gear rack 84′ integrated onthe outer surface 82′b of belt 82′, as shown in FIG. 12. In zip-tie 80′,head or case 86′ includes a ratchet (not shown) adapted to lock the gearrack on the outer side of the loop. In this embodiment, the innersurface 82 a′ of the loop is smooth, which is suitable for more fragiletissue type.

FIG. 13 shows a zip-tie 90 in a further embodiment. As shown, zip-tie 90has gear rack 94 integrated on the outer surface 92 b of belt 92.Moreover, belt 92 also includes multiple protuberances or ridges 98 onthe inner surface 92 a of belt 92 to provide a certain level of frictionor resistance between the tissue and the zip-tie. In the embodimentshown, the protuberances are in a triangular-like shape, however,protuberances or ridges can have various suitable shapes andconfigurations. Alternatively, the inner surface 92 can have texturedsurface, such as grooves, indentations, pores, or surface roughness.

In all embodiments described above, the tail of the zip-tie may alsohave a surface texture such as ribs, teeth, gear rack and grooves in thedirection transverse to the longitudinal axis of the zip-tie. Thesurface texture provides means for mechanical gripping when an automatedapplicator is used. In one embodiment, the tail of the zip-tie mayoptionally include a gear rack 84 a as shown in FIGS. 11 and 11A. In oneconfiguration, this tail gear rack is the same as the gear rack 84 anddisposed on the same side as the gear rack 84 provided at the beltportion, and with this configuration the tail portion can be locked intothe head with the same mechanism used in the belt portion. In anotherconfiguration, the tail gear rack can be on either side of the tail, forengagement with gripping mechanism of zip-tie applicator as describedhereinafter.

The zip-tie can be made of biocompatible materials, suitable forsurgical use, and can be produced by plastic molding or other suitablemethods known in the art. In one embodiment, the entire zip-tieincluding the case and the belt is made of one material. In anotherembodiment, the inner side and the outer side of the belt are made oftwo different materials. For example, the outer side is made of a moresturdy material to support the gear rack, and the inner side is made ofa resilient material with surface roughness or textures. The twodifferent sides can be joined together by heat, surgical adhesives, orother suitable materials or methods to form an integral belt. Suitablematerials for making the zip-tie includes, but are not limited to,synthetic polymers, such as nylon, silicone, and other suitable surgicalplastics.

The zip-tie can be either fastened circumferentially around the tubularorgan manually, or mechanically using a zip-tie applicator in alaparotomy or laparoscopic procedure, or in a natural orifice procedure,such as insertion through the mouth, anus, vagina, urethra, or othernatural orifice.

FIG. 14 illustrates a zip-tie applicator in one embodiment of thepresent invention. As shown, zip-tie applicator 100 includes anelongated shaft 110, a handle 120 connected to shaft 110 on one end, anda zip-tie tensioner 130 connected to shaft 110 on the opposing end. Inthe embodiment shown, zip-tie tensioner 130 includes two semi-circularmembers, or curved jaws 132 and 134 connected to each other by a hinge139. The open end 134 a of semi-circular member 134 can be attached tothe fixed end 132 a of semi-circular member 132, which forms a circularclosure. The plane of semi-circular members 132 and 134 is at about 90degree angle from the longitudinal axis of elongated shaft 110. On theinterior side 132 c of semi-circular member 132, there are two parallelgrooves 132 d and 132 e, which are continued by parallel grooves 134 dand 134 e on the interior side 134 c of semi-circular member 134. Thereis a distance between grooves 132 d and 132 e, as well as between 134 dand 134 e, sufficient for insertion of a cutting edge for dissectingtissue between two fastened zip-ties. When in use, two zip-ties areplaced into the grooves, one in grooves 132 d and 134 d, and one ingrooves 132 e and 134 e. When semi-circular member 134 is closed, atensioning or fastening mechanism (not shown) disposed within thesemi-circular members fastens the zip-ties, with a tubular organtightened within. It is noted that various zip-tie tensioning mechanismsare known in the art, and can be used for zip-tie applicator of thepresent invention. Preferably, the tensioning mechanism is operated by amotor disposed with one of the semi-circular members. Furthermore,preferably, the zip-tie applicator further includes a belt cutting bladedisposed within one of the semi-circular members, which is adapted tocut the belt after the zip-tie is fastened. Moreover, handle 120 canfurther include a control mechanism which is connected to zip-tietensioner 130 through shaft 110. In a further embodiment, the zip-tieapplicator can further include two semi-circular blades (not shown)disposed in semi-circular members 132 and 134 between grooves 132 d and132 e, and grooves 134 d and 134 e respectively. When two zip-ties arefastened as described above, the two blades can be activated by themotor to dissect the tubular organ fastened by the zip-ties. In theembodiment shown in FIGS. 14 and 14A, the curved jaws 132 and 134 aretransverse to the elongated shaft 110, and in an alternative embodimentthe curved jaws are aligned with the elongated shaft. The structure andmechanism of the zip-tie applicator are further described later afterthe description of the zip-tied anastomosis surgery method.

FIG. 15 thru 18 illustrate an example of the zip-tied anastomosissurgery method of the present invention, using zip-tie applicator 100 inan open rectosigmoid resection surgery. As illustrated in FIGS. 15 and16, in an open rectosigmoid resection surgery, after the rectosigmoidregion is exposed following the existing surgical procedure,semi-circular members 132 and 134 of zip-tie tensioner 130 of zip-tieapplicator 100 is placed around the rectum 20 at a selected dissectingsite 2. Zip-tie tensioner 130 carries two zip-ties therein. Zip-tieapplicator 100 is activated using a control mechanism on the handle tofasten two zip-ties circumferentially around the rectum 20 in parallel.Then, zip-tie applicator is triggered again to dissect the rectum 20 inthe space between the two fastened zip-ties 152 and 154 using the bladescarried with the semi-circular members. Alternatively, zip-tieapplicator 100 is removed after fastening the zip-ties, and the rectum20 is manually dissected in the space between the two fastened zip-ties152 and 154 by the surgeon. As shown in FIG. 16, this results in twozip-tied dissecting ends, one zip-tied end 24 b is a zip-tied closure ofthe rectum stump, and the other zip-tied end 34 b is a zip-tied closureof the colon 30. As further shown in FIG. 16, subsequently the targetsegment 35 in the colon 30 is resected at a resecting site 36, either bya linear cutter 76 or other surgical blades, which results in a freeresected end 38.

After resection, the rectum 20 and the colon 30 are rejoined using anexisting circular stapler. It is noted that for the purpose of thepresent invention, various commercially available circular staplers,such as DST circular staplers manufactured by Covidien (Norwalk, Conn.),CDH circular staplers manufactured by ETHICON ENDO-SURGERY (Cincinnati,Ohio), and the circular staplers manufactured by Power MedicalInterventions (Langhorne, Pa.) can be used.

As illustrated in FIG. 5, anvil 60 is placed into the lumen of the colon30 from the resected end 38 with anvil shaft 66 remaining outside ofresected end 38. Then, the resected end 38 is centrally fastened.Preferably, a third zip-tie 156 is fastened circumferentially aroundresected end 38, which fastens the colon 30 onto anvil shaft 66 to forma zip-tied resected end 38 b, as shown in FIG. 20. The third zip-tie canbe fastened either manually by the surgeon or using a zip-tie tensioner.This zip-tie tensioner may have the same or different structure fromzip-tie tensioner 130 of zip-tie applicator 100. To fasten resected end38 onto the anvil shaft only one zip-tie is needed. Moreover, theresected end 38 can be more readily accessed by the surgeon in eitheropen surgery or laparoscopic surgery, therefore, the elongated shaft ofzip-tie applicator 100 is not needed. Alternatively, resected end 38 canbe tied around anvil shaft 66 by purse-belt suture. Using either thethird zip-tie or purse-belt suture, the method forms a centralizedclosure.

Then, cartridge 54 of circular stapler 50 carrying stapling and cuttingcartridge 58 is transanally inserted in the rectum 20 and advanced tothe extent that cartridge 58 is positioned against the zip-tied end 24b, and then center rod 56 is advanced to perforate the zip-tied closureadjacent to the zip-tie, as shown in FIG. 17 (cartridge 54 is within therectum 20 in FIG. 17). The point of perforation should be sufficientlyclose to the zip-tie, which is at the center of the zip-tied closure, solong as the zip-tie does not interfere with the connection between thecenter rod and the anvil shaft. To position the center rod adjacent tothe zip-tie assures the zip-tied end to be enclosed within the circle ofthe staples.

Optionally, an intraluminal guide wire can also be used to guide thecenter rod for perforation adjacent to the zip-tie. In rectosigmoidresection surgery, either laparotomic or laparoscopic procedure,sometimes it is difficult for the surgeon to see the position of thefastened closure of the rectum stump when advancing the center rod. Toassure that the center rod perforates adjacent to the zip-tie, anintraluminal guide wire can be first introduced into the zip-tied rectumstump. The guide wire can be introduced from the abdomen cavity orthrough the anus. In one embodiment, as shown in FIG. 17A, a guide wire160 is introduced from the abdomen cavity into the rectum by penetratingthe distal end 162 of guide wire 160 through the zip-tied closure at apoint adjacent to the zip-tie and the distal end 162 is taken out fromthe anus by the surgeon. Alternatively, the distal end 162 can alsopenetrate the zip-tied closure through the loop of the zip-tie. Thedistal end 162 is then fastened to center rod 56 of circular stapler 50.After the cartridge 54 of circular stapler 50 is inserted into therectum 20 transanally, the center rod 56 is advanced in a directionguided by the guide wire 160. The guide wire 160 is pulled from itsproximal end 164 by the surgeon, which assures that the center rodperforates the zip-tied closure adjacent to the zip-tie.

In another embodiment, the guide wire can be introduced transanally,which is particularly suitable for the situations of high colorectalanastomosis. In this embodiment, a flexible or rigid rectoscope can beinserted in the rectum through anus carrying guide wire 160 within. Theproximal end 164 of guide wire 160 penetrates the zip-tied closure at apoint adjacent to the zip-tie or through the loop of the zip-tie, andthe proximal end 164 is pulled up from the abdomen cavity and therectoscope is retrieved, with the distal end 162 remaining outside theanus, as shown in FIG. 17A. Then, the distal end 162 is fastened tocenter rod 56 of circular stapler 50. After the cartridge 54 of circularstapler 50 is inserted into the rectum 20 transanally, the center rod 56is advanced in a direction guided by the guide wire 160, whichperforates the zip-tied closure adjacent to the zip-tie. The guide wireis a flexible, thin wire made of metal, polymer, or other suitablesurgical plastic materials. As can be appreciated from the abovedescription, depending on the direction of penetration, either thedistal end or the proximal end of the guide wire can be referred to asthe first end or the second end.

After center rod 56 is properly positioned, center rod 56 and anvilshaft 66 are engaged and interlocked through the locking mechanismbetween the center rod and the anvil shaft. Anvil 60 (within the colon30) is pulled toward cartridge 54, along with the colon 30, untilsurface 62 of anvil 60 is against cartridge 58 (see FIG. 4A also). Then,circular stapler 50 is activated to staple the rectum 20 and the colon30 together by placing a circular double staggered row of anastomosingstaples, with the staples encircling zip-tied end 24 b and zip-tiedresected end 38 b. This forms stapled circular closure 8 b between therectum 20 and the colon 30, as shown in FIG. 18. Then, the circularblade disposed within cartridge 54 cuts through the colon and the rectuminside the double rows of staples, and cartridge 54 is removedtransanally together with anvil 60, the cut tissues and the zip-tie,which results in a smooth recreated colorectal pathway.

As shown in FIG. 18, using the zip-tied colorectal anastomosisprocedure, the stapled circular closure 8 b formed in the final step hasa smooth interface between the rectum 20 and the colon 30. The areas oftissues being stapled are fresh and intact, absent any stitches orstaples. Therefore, it substantially reduces the risks of leakage at theinterface region and surgical complications. Since no overlap betweendifferent closures, such as those present in double and triplingstapling anastomosis procedures, the zip-tied colorectal anastomosisprocedure has the advantages of less tissue scarring, and consequentlyless stricture of the recreated pathway.

As can be understood, this type of circular stapled interface can alsobe achieved using manual suturing procedure, where both the dissectedend 24 of the rectum and the resected end 38 of the colon are manuallysutured as shown in FIG. 10 and FIG. 9, respectively. However, asdescribed earlier, manually suturing the dissected end 24 of the rectumis a very difficult process and often impossible to perform. Using thezip-tied colorectal anastomosis procedure of the present invention, therectum can be readily fastened by zip-ties. Particularly, with theassistance of the zip-tie applicator, even the lower portion of therectum can be readily fastened and dissected. This process has theadvantage of shorter surgery time of the existing double or triplestapling anastomosis procedures, yet free of the inherent disadvantagesof linear stapling methods.

The zip-tied anastomosis method can also be used in transabdominalend-to-end colorectal anastomosis procedure, which typically has thedissecting site at a higher portion of the rectum. In this surgicalprocedure, after initial dissection using double zip-ties as describedabove, the zip-tied dissected end 24 of the rectum can be reopened bycutting off the zip-tied portion, then anvil 60 of the circular stapleris placed into reopened dissected end 24 and the dissected end 24 iscentrally fastened by a third zip-tie, with anvil shaft 66 stayingoutside. After resection of the target segment in the colon, theresected end 38 of the proximal colon is centrally fastened by a fourthzip-tie. An incision is made on the wall of the colon, and the cartridge54 of the circular stapler is inserted into the colon through theincision, with the cartridge 58 placed against the zip-tied resectedend, and the center rod 56 perforating the zip-tied closure adjacent tothe zip-tie. Then, the center rod and the anvil shaft are joined and theanvil shaft is closed against the cartridge. The circular stapler isthen activated to staple the rectum and the colon together, which formsstapled smooth circular closure, as described above. In this procedure,after cutting the tissues encircled inside the staples, the headtogether with the anvil, cut tissues and the zip-ties are removed fromthe incision on the wall of the colon, and the incision is closed bypurse-belt suture.

Furthermore, the zip-tied anastomosis method can be used in laparoscopicsurgery. In laparoscopic surgery within the abdominal or pelviccavities, a small incision is made on the abdomen of a patient, and thena zip-tie applicator can be inserted into the pelvic cavity to dissectthe colon from the rectum as described above in the open surgery, whichis monitored using a laparoscope. After dissection, the zip-tied end 34b of the colon 30 is taken out from the pelvic cavity through the smallincision 9, as shown in FIG. 19. Then, as described in the open surgeryprocedure, the target segment 35 is resected, which forms a resected end38. The circular stapler 50 is used to rejoin the colon and the rectum.As shown in FIG. 20, anvil 60 is placed into the proximal colon, andresected end 38 is fastened by a third zip-tie 156 onto anvil shaft 66.Then, the zip-tied colon is placed back into the pelvis cavity throughthe small incision 9. As described previously in the open surgery andshown in FIG. 17, the cartridge 54 of the circular stapler 50 isinserted into the rectum 20 transanally, and placed against the zip-tiedend 24 b with the center rod 56 perforating the zip-tied closureadjacent to the zip-tie. Then, center rod 56 and anvil shaft 66 arejoined, and the anvil is closed against the cartridge. The circularstapler is then activated to staple the rectum 20 and the colon 30together, which forms stapled smooth circular closure, as describedabove. After cutting the tissues encircled inside the staples by thecircular stapler, the head, together with the anvil, cut tissues and thezip-ties are removed from anus, which forms the recreated colorectalpathway. The small incision on the abdomen is then closed by purse-beltsuture.

For laparoscopic zip-tied anastomosis surgery, the zip-tie applicatormay have a different structure. The zip-tie tensioner may comprise twosemi-circular members, with one end of both semi-circular memberspivotally attached to the elongated shaft. The semi-circular members areadapted to open and close as controlled by the control mechanism on thehandle. Moreover, the two semi-circular members may also connect to theelongated shaft by a second pivot, which enables the plane of thesemi-circular members to be adjusted at a desired angle when the zip-tietensioner is advanced inside the pelvis cavity to the dissecting site.

In a further aspect, the present invention provides surgical stringapplicators for applying one or more surgical strings or surgical tiesaround a subject tubular organ in the anastomosis method describedabove. Herein, the term “surgical string” or “surgical tie” refers to anelongated flexible element having a cross sectional shape ofrectangular, square, oval, circular, semicircular, or other geometricconfigurations. Surgical strings can be made of biocompatible, surgicalgrade, plastic materials, silicon, fiber, other materials suitable forsurgical use. Optionally, the surgical strings may include surfacetextures. Moreover, surgical strings may also include self-lockingmechanism such as a zip-tie. Exemplary embodiments of surgical stringsinclude, but not limited to, flat straps, zip-ties, and surgical suturesor threads. In the anastomosis method described above the process isillustrated with zip-ties, however, other surgical strings can also beused, particularly with assistance of the applicators. Therefore, theanastomosis method of the present invention is also referred to as amechanically assisted string-tied anastomosis method.

FIGS. 21-29 illustrate several exemplary embodiments of surgical stringapplicators of the present invention, in addition to the embodimentshown in FIGS. 14 and 14A. When the surgical string applicator isdesign, or suitable, to apply zip-tie, it is also referred to as zip-tieapplicator interchangeably.

FIGS. 21 and 21A show a surgical string applicator 200 in one embodimentof the present invention. As shown, surgical string applicator 200includes an elongate hollow shaft 210, a handle portion 230 connected toproximal end 212 of shaft 210, and a string applying assembly thatincludes opposed first and second jaws 320, 340 connected to distal end214 of shaft 210 and a string fastening mechanism adapted to engage andfasten one or more surgical strings such as zip-ties that will be placedwithin the jaws and will be applied to a tubular organ, as describedhereinafter.

In surgical string applicator 200, each of jaws 320, 340 has a curvedshape, generally semicircular, with the concave inner side facing theopposing jaw. The two curved jaws 320, 340 are aligned with each other,and are also aligned with elongated shaft 210, namely with thelongitudinal axis of the jaws (from the proximal end 322, 342 to thedistal end 324, 344) aligned with the longitudinal axis of shaft 210.The proximal ends 322 and 344 of the two jaws can be connected directly,or through an interface component, to the distal end 214 of shaft 210.At least one jaw can be pivotally moved relative to the opposing jaw, orboth jaws can be pivotally moved relative to each other. Moreover,either jaw or both can be locked at a selected position. Furthermore,the pair of jaws can also be articulated relative to and rotated aboutthe longitudinal axis of the elongated shaft, to facilitate positioningthe jaws relative to a subject tubular organ. The rotation can beeffected by either rotating the pair of jaws relative to the shaft, orby rotating the shaft itself. In the embodiment shown in FIG. 21A, boththe first and the second jaws can be pivoted at their proximal ends.When jaws 320, 340 are closed, their distal ends 324 and 344 are againsteach other. As can be appreciated, when the curved jaws are opened, atubular organ can be received through the opened distal ends 324 and344, and then is captured or surrounded by jaws 320, 340 when the jawsare closed.

The dimensions of the jaws in surgical string applicator 200 can bedetermined according to particular surgery procedures where the deviceis used. For use in colorectal anastomosis surgery, typically the jawsmay have a length (defined as the distance from the proximal end to thedistal end at the outside of the jaws) from about 30 to about 80millimeters (mm), and an outer cross-width (defined as the maximumdistance between the outside of the two jaws in the direction transverseto the longitudinal axis of the jaws when the jaws are closed)preferably equal or less than the length. The jaws may have a width(transverse to the longitudinal direction of the jaw) from about 10 mmto about 30 mm, and a thickness (from the inner surface 326 to the outersurface 328 thereof, see FIG. 23A) from about 4 mm to about 12 mm,depending on the structural components in the jaw as describedhereinafter. In one exemplary embodiment, the closed jaws have a lengthand an outer cross-width about 50 mm and an inner cross-width (definedas the maximum distance between the inside of the two jaws in thedirection transverse to the longitudinal axis of the jaws when the jawsare closed) about 40 mm. The shaft typically has a diameter from about 8mm to about 12 mm and the length can be from about 150 mm to about 350mm, depending on the surgery procedure. As can be appreciated, for atubular organ of smaller size, such as artery, the inner cross-width ofthe jaws can be smaller. Moreover, as described hereinafter, forlaparoscopic surgery, the shape and dimension of the jaws can bedifferent to meet the small incision requirement.

FIGS. 22 and 22A show a surgical string applicator 200 a in analternative embodiment. As shown, surgical string applicator 200 aincludes a first straight jaw 320 a and a second curved jaw 340 a, bothhaving the proximal ends 322 a and 342 a connected to distal end 214 aof shaft 210 a. As shown in FIG. 22A, in this embodiment the first jaw320 a is fixed, and the second curved jaw 340 a pivots at its proximalend 342 a to open and close the distal end 344 a relative to the distalend 324 a of the first jaw 320 a. As can be appreciated, with thisconfiguration the contact or mutual engagement between the two jaws isbetween the extreme distal end of the second jaw 340 a and the innerside (the upper side in FIG. 22A) of the distal end of the first jaw 340a. The first and second jaws 320 a, 340 a can have the same length asjaws 320 and 340 of surgical string applicator 200 described above.However, the inner cross-width between the closed jaws 320 a and 340 amay be about half of that between jaws 320 and 340 described above, ifjaw 320 a has the same curvature as that of jaw 320. As can beappreciated, this configuration has a less dimension in the directiontransverse to the longitudinal axis, which facilitates positioning ofthe jaws in limited spaces. Similar to that described in applicator 200,the pair of jaws in applicator 200 a can also be articulated relative toand rotated about the longitudinal axis of the elongated shaft.

Further structures and operating mechanisms are now described usingsurgical string applicator 200, with exemplary structures adapted toapply zip-ties. Surgical string applicator 200 a may have similar ordifferent structures. In one embodiment, each of the two jaws 320 and340 of surgical string applicator 200 has one or more grooves along theinner surface of the jaw. As shown in FIGS. 23 and 23A, first jaw 320includes two parallel grooves 332 and 334 on inner surface 326 of thejaw, with a predetermined distance therebetween. The predetermineddistance between grooves 332 and 334 corresponds to the distance betweentwo zip-ties at the dissecting site for dividing the tubular organ by ablade. As such, this distance is also referred to herein as acut-distance. Typically, the cut-distance can be from about 5 mm toabout 20 mm, preferably from about 8 mm to about 16 mm; however, it mayvary for different tubular organs.

Grooves 332 and 334 are recessed from and disposed linearly along innersurface 326. The width of each groove can be equal or greater than thewidth of a surgical zip-tie for receiving the zip-tie therein, with theplanar surface of the zip-tie placed on the bottom of the groove. FIG.23A shows a cross-section of the structure of grooves 332 and 334 in oneexemplary embodiment shown in FIG. 23, with a zip-tie 800 placedtherein. As shown, groove 332 has a channel-like structure, including aplanar bottom 332 a, a straight side wall 332 b on one side, aprotruding upper rim 332 c on the other side, and a top opening 332 d.The bottom 332 a has a width substantially greater than the width ofzip-tie 800, the zip-tie can be disposed underneath upper rim 332 c inits resting stage. The top opening 332 d has a width similar to orslightly greater than the width of the zip-tie. The upper rim 332 c hasa curved or inclined lower surface, facing the upper surface of thezip-tie. As such, when zip-tie 800 is pulled at its tail by the stringfastening mechanism, the tensioning force causes the zip-tie slidingagainst the curved lower surface of the upper rim 332 upwardly andreleases the zip-tie through top opening 332 d. For holding a zip-tiewithin the groove, the upper rim can be continuous, or be present inseparate segments, along the length of the groove. In the embodimentshown, groove 334 has the same structure of groove 332, with a reversedorientation. However, groove 334 can also have the same orientation ofgroove 332. In either case, the distance between the two top openings isthe cut-distance, and in the embodiment shown it corresponds to thewidth of ridge 310 between grooves 332 and 334.

As further shown in FIG. 23B, distal end 324 of jaw 320 includesrecesses 333 and 335, each at the distal end of one of the two grooves332 and 334. Each recess extends below the bottom of the groove, whichforms an alcove for receiving the head of one zip-tie, with the openingof the passage in the head facing the outmost end of jaw 320 toward theopposing jaw. Each recess has dimensions complimentary to the dimensionsof the head of a zip-tie to be used. As further shown, each recess has arear opening 333 a or 335 a on the proximal end of the recess underneaththe corresponding groove 332, 334. The rear openings are used to receivethe tail of a zip-tie after it passes through the head of the zip-tie.In one embodiment, the rear openings 333 a and 335 a are connected to achannel 360 underneath the grooves shown in FIG. 23A, which is used forone type of string fastening mechanism in an exemplary embodimentdescribed hereinafter.

Similarly, second jaw 340 has two parallel grooves 352 and 354 that havethe same structure of grooves 332 and 334 described above. Grooves 352and 354 of the second jaw 340 are in alignment with grooves 332 and 334of the first jaw 320, respectively, for receiving two zip-ties in thealigned grooves between the two jaws. However, the distal end of secondjaw 340 does not include the recesses described above, since tailportion of the zip-ties is placed into grooves 352 and 354. In thesecond jaw, the grooves may have different depths toward distal end 344.As can be appreciated, to engage the tail end of a zip-tie with the headof the zip-tie disposed within recess 333 or 335 at the distal end ofjaw 320, the distal ends of grooves 352 and 354 are deeper to ensurealignment between the tail and the passage in the head of the zip-tie,which can be viewed in FIG. 25. It should be understood that thestructures of the two opposing jaws described above can be reversed. Inother words, jaw 340 may have the recesses and jaw 320 may have thecomplimentary structure for head-tail engagement of the zip-ties.

In the embodiment shown, each jaw has two grooves for receiving twosurgical zip-ties and applying them around a tubular organ. However,each jaw may also have only one groove for receiving and applying asingle zip-tie. This may occur in a situation where a single tie isfirst applied immediately next to a tumor to prevent spreading of cancercells, prior to applying double zip-ties for dissecting the tubularorgan as described above. Furthermore, each jaw may also have fourgrooves along inner surface 326 of the jaw. This configuration may beused to fasten two pairs of zip-ties, with each pair on one side of thedissecting site. In this case, the first and second grooves may beimmediately next to each other, so are the third and fourth grooves; andthe cut-distance is positioned between the inner grooves, namely thesecond and third grooves. Moreover, each jaw may also have threegrooves. In this configuration, one groove is on one side and twogrooves immediately adjacent to each other are on the other side, withthe cut-distance therebetween. The cut-distance can be either positionedbetween the first and the second grooves, or positioned between thesecond and the third grooves.

The string fastening mechanism can be designed and integrated into thesurgical string applicator in various different ways, which isillustrated hereinafter in reference to exemplary embodiments. In oneembodiment, the string fastening mechanism comprises a tie grippingmember disposed within one of the jaws adapted to grip a portion of azip-tie placed within the jaws and a tightening mechanism adapted tofasten the gripped zip-tie. In one exemplary embodiment shown in FIGS.23-23B, the first jaw 320 further includes channel 360 underneathgrooves 332 and 334, and a tie gripping member 370 is disposed at thedistal end of channel 360 (also see FIG. 24). The distal end of channel360 is closed, except the openings 333 a and 335 a which connectschannel 360 with recesses 333 and 335. In one embodiment as shown inFIGS. 24 and 24A, tie gripping member 370 comprises a chuck 372 thatincludes two passages 374 a and 374 b therethrough, and within each ofthe passages a barb 376 having one or more barb teeth 376 a as shown inFIG. 24A. As can be appreciated, the engagement and interlockingmechanism of chuck 372 with a zip-tie are the same as those between thetail and the head of a zip-tie. Chuck 372 is positioned at the distalend of channel 360 with the opening of passages 374 a and 374 b facingand aligned with the openings 333 a and 335 a. Chuck 372 is connected tothe tightening mechanism that includes an interface member 202 and adriving mechanism 240 disposed within elongated shaft 210 and handleportion 230. In one embodiment, tie gripping member 370 further includesa strap 379 with one end connected to chuck 372 and the opposing endcoupled to the driving mechanism through the interface member. Chuck 372can be moved from the distal end toward the proximal end of channel 360by the driving mechanism.

In one embodiment, the interface member 202 is a releasable clampingelement, such as a spring-loaded clamp or other suitable mechanicalgripping mechanisms, disposed inside the distal end of shaft 210, whichclamps strap 379. The driving mechanism 240 includes a motor and a powersupply disposed in the handle portion 230 and a connection meansdisposed in shaft 210, such as a rod, gears, or other suitable means,which interconnects the clamping element and the motor. The drivingmechanism pulls the clamped strap 379 in the direction toward theproximal end of the shaft. Once the zip-tie is fastened, the clampingelement is opened by a control mechanism in the handle portion torelease the strap. Alternatively, if the surgical string applicator ismanually operated, the chuck can be moved through the connection meansby manual mechanical drive operated by the handle portion.

As can be appreciated, instead of a single chuck, tie gripping member370 can include two chucks, each thereof including a passagetherethrough and a barb disposed within the passage. Each chuck isconnected to a strap, which is then coupled to the driving mechanism.Alternatively, the two chucks are bridged together, and a single strapis connected to the bridged chucks. Moreover, in an alternativeembodiment chuck 372 is connected to a gear that is coupled with a gearrack provided in channel 360, and the gear is driven by the drivingmechanism in the shaft and the handle portion. In this configuration,the gear and gear rack may also be coupled to the interface member ofthe driving mechanism.

When in use, two zip-ties 800 are placed into and along the two groovesof the jaws, with their heads 810 disposed at the distal end of one jawand their tails 830 disposed at the distal end of the opposing jaw, seeFIG. 25. Zip-tie 800 has the gear rack on one side of belt portion 820and also on one side of tail 830. Heads 810 of the two zip-ties areabove chuck 372, with the passage within the first head aligned withpassages 374 a and the passage within the second head aligned withpassage 374 b of chuck 372, respectively, see FIG. 25A (only one head isshown in the cross-sectional view). When jaws are closed by a controlmechanism in the handle portion, the tail 830 of the first zip-tie iscaused to insert into head 810 of the first zip-tie and further intopassage 374 a of chuck 372 underneath, and the tail of the secondzip-tie is caused to insert into the head of the second zip-tie andfurther into passage 374 b of chuck 372, respectively, see FIG. 25B(only one head is shown in the cross-sectional view). As such, theengagement between the gear rack on the tail 830 of zip-ties 800 andbarb teeth of chuck 372 locks tails 830 of the zip-ties into chuck 372.Then, the driving mechanism is actuated to pull chuck 372, together withtails 830 locked therein, from the distal end 324 of jaw 320 toward theproximal end 322, which results in fastening of zip-ties 800, asillustrated in FIG. 25C. As can be appreciated, the gear rack can be oneither side of tail 830, so long as chuck 372 is orientated in themutual locking direction. As can be further appreciated, alternativelyother gripping mechanisms may also be used in lieu of the chuckdescribed above.

Different mechanisms can be used to facilitate initial engagement of thetail and the head of the zip-tie. In one exemplary embodiment asillustrated in FIGS. 25-25B, the distal ends of the curved jaws are soconfigured that when the jaws move from an open position to the closeposition, the tail and head of the zip-tie become engaged with theclosing movement. As shown in FIG. 25, the first jaw 320 is a semicircleabout 180 degree and has the structures described above, while thesecond jaw 340′ is a semicircle about 200 degree, including a protrudingsegment 344 a at the distal end of the jaw. As shown in FIGS. 25 and25B, protruding segment 344 a has a dimension slightly larger than, andcomplementary to, the distal end 324 of the first jaw 320. As shown inFIG. 25, when a zip-tie 800 is placed into the grooves, tail 830 isdisposed within protruding segment 344 a of the second jaw 340′, whichextends out from groove 352′. As illustrated in FIG. 25B, with thisconfiguration when the second jaw 340′ is brought to a complete closedposition against the first jaw 320, protruding segment 344 a of thesecond jaw 340′ extends into the region of, and overlaps with, thedistal end 324 of the first jaw 320. This extended move brings the tail830 of the zip-tie forward and causes the tail 830 entering into head810 disposed at the distal end 324 of the first jaw 320, and furtherentering into chuck 372 of the tie gripping member, as described above.In an alternative embodiment, the protruding segment 344 a of the secondjaw is not present, only the tail of the zip-tie is placed extendingbeyond the grooves in the same manner shown in FIGS. 25 and 25A. As canbe appreciated, with either configuration the zip-tie used has a lengthgreater than the circumferential length of the inner loop formed by thetwo jaws.

In a further alternative embodiment, both first and second jaws aresemicircles about 180 degree, when a zip-tie is placed into the grooves,the tail of the zip-tie flushes with the distal end of the groove of thesecond jaw. In this configuration, the string applying assembly furthercomprises a tie advancing mechanism 302 disposed within the second jaw,on the side of or underneath the groove. The tie advancing mechanism 302includes a grasping member adapted to engage with either the belt or thetail portion of the zip-tie. As can be appreciated, in this embodimentthe tail may have surface textures facilitating engagement with thegrasping member. The tie advancing mechanism can be actuated by a seconddriving mechanism disposed in elongated shaft 210 and handle portion230. When in use, the first and second jaws are brought into a completeclosed position, with their distal ends against each other. Then, thetie advancing mechanism is actuated, which engages the belt portion orthe tail portion of the zip-ties and pushes the tail forward toward thedistal end of the first jaw, which causes the tail entering into thehead and into the chuck of the tie gripping member described above. Withthis configuration, the zip-tie used may have a length equivalent to thecircumferential length of the jaws.

The string fastening mechanism of the surgical string applicator isdescribed in reference to the exemplary embodiment that has two parallelgrooves within the jaws. However, as can be understood by those ofordinary skill in the art that the same mechanism can be used for thejaws that includes only one or more than two grooves. In thoseconfigurations, the chuck of the tie gripping member includes the numberof passages corresponding to the number of grooves. Alternatively,different number of chucks may be provided corresponding to the numberof grooves.

In another exemplary embodiment, a different approach is used to fastenthe zip-ties. For simplicity, the structure and mechanism are describedin reference to only one groove in each of the first and second jaws. Inthis configuration, the groove structure can be the same as thosedescribed above and the string fastening mechanism can have the sametightening mechanism described above; however, the tie gripping memberas wells as the channel underneath the groove for placing and moving thetie gripping member are not present. As illustrated in FIG. 26, in thisembodiment two shorter and mutually connected zip-ties 920 a and 920 bare used to facilitate fastening a tubular organ received within thejaws. Each of zip-ties 920 a and 920 b has a length similar to, orgreater than, the longitudinal length of one jaw, and the two zip-tiesmay have a same or different length. As shown, the first zip-tie 920 ahas a head 910 a and a tail 930 a, and the second zip-tie 920 b has ahead 910 b and a tail 930 b. Before placing them into the jaws, the tail930 a of the first zip-tie 920 a is inserted and locked into the head910 b of the second zip-tie 920 b. This forms a head-tail connectionbetween the two zip-ties, hence, zip-ties 920 a and 920 b are hereinreferred to as head-tail connected zip-ties. When the connected zip-ties920 a and 920 b are placed into the jaws, head 910 a of the firstzip-tie 920 a is positioned at the distal end of the first jaw and tail930 b of the second zip-tie 920 b is positioned at the distal end of thesecond jaw, with the orientation illustrated in FIG. 26 without showingthe jaws. As such, the mutually joined head 910 b of the second zip-tie920 b and the tail 930 a of the first zip-tie 920 a are located at theproximal ends of the jaws, next to the distal end 214 of shaft 210. Inthis embodiment, the tail 930 a of the first zip-tie 920 a is insertedinto and locked by the claiming element of the tightening mechanism,disposed inside the distal end 214 of shaft 210 as described above. Thedriving mechanism pulls the tail 930 a of the first zip-tie 920 a in thedirection toward the proximal end of the shaft. Once the loop formed bythe two head-tail connected zip-ties is fastened, the clamping elementis opened to release the tail 930 a of the first zip-tie 920 a.

When in use, a tubular organ is received between the first and secondjaws and the jaws are closed by the control mechanism in the handleportion as described above. The initial engagement between the tail 930b of the second zip-tie 920 b with the head 910 a of the first zip-tie920 a can be effected using the same mechanisms described above. In oneembodiment shown in FIG. 27, the first jaw 320′ has same structures ofjaw 320 described above, but without channel 360, and the distal end ofthe second jaw 340′ has the same structures shown in FIG. 25, whereinthe tail 930 b of the second zip-tie 920 b is extended beyond thegroove. When the second jaw is brought into a complete closed position,the tail 930 b of the second zip-tie 920 b is caused to enter into thehead 910 a of the first zip-tie 920 a (see FIG. 26). It is noted that inthis case the tail 930 b of the second zip-tie 920 b may extend in alesser degree beyond the groove, since the tail 930 b only engages withthe head of the first zip-tie, but not with the chuck of the tiegripping member. In another embodiment, a tie advancing mechanismdisposed in the second jaw can be used to facilitate the initialengagement between the tail 930 b of the second zip-tie 920 b and thehead 910 a of the first zip-tie 920 a, as described above.

After the tail 930 b of the second zip-tie 920 b is locked into the head910 a of the first zip-tie 920 a, the tightening mechanism can beactuated using a trigger on the handle portion. The driving mechanismpulls the clamping element, together with the tail 930 a of the firstzip-tie 920 a locked therein, toward proximal end of the elongatedshaft. This results in fastening of the loop formed by the two zip-tieswithin the jaws 340′ and 320′, as shown in FIG. 27.

In a further embodiment, optionally the surgical string applicatorfurther includes a blade disposed within one of the jaws. In oneexemplary embodiment, the blade 304 is positioned within a recess in theridge 310 between the grooves in one of the jaws. The blade 304 isdisposed along the longitudinal axis of the jaw, preferably, at thecenter between the two grooves. Moreover, the blade is positionedadjacent to the position of the head of zip-tie within the jaw, sincethe tissue is fastened against the head. In other words, in theembodiment where a zip-tie is fastened against its own head at thedistal end of the jaw as illustrated in FIG. 25C, the blade is disposedat the distal end of a jaw. However, in the other embodiment where twohead-tail connected zip-ties are used and the loop is fastened at theproximal ends of the jaws (see FIG. 27), the blade is disposed at theproximal end of a jaw. One end of the blade can be pivotally attached tothe lower portion of the recess, when being actuated the blade rotatesaround the pivot point, which cuts the tissue between two fastenedzip-ties. Prior to actuation, the blade is hidden completely within theridge. The length of the blade is sufficient to dissect the tubularorgan fastened by the zip-ties, and the blade can be straight or curveddepending on the shape of the jaws and the position of the blade. Theblade can be actuated by a control mechanism in the handle portion 230.Moreover, the surgical string applicator may further include a secondblade disposed within one of the jaws for cutting the zip-tie adjacentthe head thereof after fastening the zip-tie. The second blade can bedisposed at either the distal end or proximal end of the jaws, dependingon the location where the zip-tie is fastened as described above. In theembodiment shown in FIG. 27, the second blade can also be disposed inthe distal end of the elongated shaft. The second blade is positioned tocut the zip-tie in the direction transverse to the longitudinal axis ofthe jaws.

The string fastening mechanism of the surgical string applicators aredescribed above in particular reference to applying zip-ties that have aself-locking mechanism. However, as can be appreciated, the surgicalstring applicators of the present invention can also be structured toapply other surgical strings that do not have a self-locking mechanism.For example, the distal end of one jaw may have openings complementaryto the tail of the surgical strings disposed at the distal end of theopposing jaw, to receive the tail portion of the surgical strings whenthe jaws are brought into closed position (similar to openings 333 a and335 a in FIG. 23B). The inserted tail of a surgical string can begripped by a gripping means adjacent the openings and tightened atdistal end in a manner similar to those described above, then theoverlapping portion of the tightened surgical string can be joined by afasten means, such as clamp, locking pin, surgical glue or othersuitable means, applied within the jaw where the overlapping portion isin. It is further noted that the structural components for facilitatingengagement of different portions of a surgical string can also be placedat the proximal ends of the opposing jaws, when the jaws open and closeat their proximal ends as illustrated in the embodiment shown in FIG.29B.

Handle portion 230 can assume any ergonomic shape or geometry that canbe held and operated by one hand. Handle portion can include one or moretriggers coupled thereto for opening and closing the jaws, and actuatingthe string fastening mechanism. In the embodiment shown in FIG. 21, afirst trigger 232 movably coupled to handle 230 for opening or closingthe opposed jaws 320 and 340, and locking the jaws at a selectedposition. First trigger 232 can be pulled or pushed laterally to effectopening or closing of the jaws. Alternatively, two separate triggers canbe used to effect opening or closing of the jaws. For opening andclosing the curved jaws, various known mechanisms used for opening andclosing linear surgical staplers can be used for the purpose of thepresent invention. In one exemplary embodiment, actuation of firsttrigger 232 is effective to slide a closure tube over proximal ends 322,342 of jaws 320, 340 to close the jaws, or to slide the closure tubeaway from the proximal ends to open the jaws. Handle portion 230 furtherincludes a second trigger 234 movably coupled thereto for actuating thestring fastening mechanism. The second trigger, or an additional trigger(not shown), may also be effective to actuate the blade. While notshown, handle portion 230 can additionally or alternatively includetriggers, rotatable knob, lever, sliding knob, or other mechanisms foropening and closing the jaws, articulating the jaws, rotating theelongated shaft, actuating the string fastening mechanism, and actuatingthe blades. These triggers are jointly referred to as controlmechanisms, which can be powered by the power supply such as a batteryenclosed in the handle portion. Alternatively, the triggers can also beactivated manually.

In one embodiment, the pair of jaws of the surgical string applicatorcan be hinged together as a module, which can be attached to or removedfrom the elongated shaft. Moreover, the entire module can be disposable,which is provided as a sterilized package, with zip-ties preloadedwithin the grooves. Alternatively, the inner side of the jaws includingthe components described above can be provided as a disposable cartridgewith zip-ties preloaded within the grooves, while the outer shells ofthe jaws remain attached to the shaft. The cartridge, provided as asterilized package, can be placed into outer shells of the jaws by thesurgeon. In either case, when the disposable jaw module is attached tothe shaft, or the cartridge is placed into the outer shells of the jaws,the strap of the tie gripping member is locked into the releasableinterface member described above, which is coupled to the drivingmechanism. In the embodiment where two head-tail connected zip-ties areused, the tail 930 a of the first zip-tie 930 is locked into thereleasable interface member as described above.

In surgical string applicator 200 described above, the two curved jawsare aligned with the elongated shaft. However, it should be understoodthat the pair of jaws can also have different orientation relative tothe shaft. FIG. 28 illustrates a surgical string applicator 400 in afurther embodiment of the present invention. In this embodiment, the twocurved jaws 420 and 440 are disposed transverse or perpendicular toelongated shaft 410. In either embodiment, the pair of jaws can bearticulated to position the jaws at various angles relative to theelongate shaft. Moreover, the elongated shaft can be rotated 360degrees, which facilitates positioning of the jaws relative to thesubject tubular organ. The handle portion can further include one ormore triggers for articulating the pair of jaws relative to the elongateshaft and for rotating the shaft. Various driving mechanisms forarticulating the jaws or a head group relative to the shaft and rotationof the shaft have been used in linear surgical staplers, which can beused for the same purpose in the surgical string applicator of thepresent invention.

FIG. 29 further illustrates a surgical string applicator 500 in anotherembodiment of the present invention. As shown, the curved jaws 520 and540 have a substantially less curvature than the jaws in surgical stringapplicator 200, and the closed jaws 520 and 540 exhibit an ellipticalshape. These elongated curved jaws are particularly suitable forlaparoscopic surgery. In one exemplary embodiment, the jaws have alength from about 30 mm to about 80 mm, a width equal or less than 12mm, and an outer cross-width of the two jaws equal or less than 12 mm.With such a small dimension, the jaws can be introduced into the bodythrough a cannula, or trocar currently used in laparoscopic surgeries.For surgical string applicator 500, shaft 510 may have a diameter fromabout 8 mm to about 12 mm, and a length from about 250 mm to about 400mm, which also depend on the shape and length of handle portion 530. Thestructures of the grooves, the string fastening mechanism and thecontrol mechanism described above can also be used with surgical stringapplicator 500.

In one exemplary embodiment as shown in FIG. 29A, the first jaw 520 isfixed and the second jaw 540 can be pivoted at its proximal end 542,which effects opening or closing of the distal end 544 of the second jawrelative to the distal end 524 of the first jaw. Alternatively, thesecond jaw 540 may be fixed and the first jaw 520 may be pivoted at itsproximal end 522.

In a further exemplary embodiment as shown in FIG. 29B, the first jaw520′ is fixed and the second jaw 540′ has its distal end 544′ pivotallyconnected to the distal end 524′ of the first jaw. FIG. 29B shows thetwo elongated jaws in a completely open position, in which the distalends 524′ and 544′ and proximal ends 522′ and 542′ of the first andsecond jaws are all on the same plane, with the two proximal ends 522′and 542′ disposed at two opposing ends. With this embodiment, when inuse, the jaws can be inserted through a trocar into the body at itscomplete open position shown in FIG. 29B. Then, after placing thesubject tubular organ on the inner surface of the jaws, the second jawis actuated by a control mechanism in the handle to rotate the secondjaw around the pivoted distal end 544′, as indicated by the arrow inFIG. 29B, which closes the proximal end 542′ of the second jaw againstthe proximal end 522′ of the first jaw. When retrieving the jaws fromthe body, the second jaw is opened again to the complete open position,and the jaws are pulled back through the trocar. As can be appreciated,this configuration is more advantageous for laparoscopic surgery,because the completely opened jaws may have only about half of the outercross-width of the closed jaws shown in FIG. 29, as such each elongatedjaws may have more dimension in thickness for conveniently placingdesired groove structure, channel, tie gripping member, or tie advancingmechanism in the jaws as described above. This reduces technicaldifficulties in design and manufacturing the surgical string applicatorfor laparoscopic surgery.

In the embodiment shown in FIG. 29B, the first jaw 520′ faces up and thesecond jaw 540′ closes downwardly. Alternatively, the first jaw may facedown and the second jaw closes upwardly. Moreover, the elongated shaftcan rotate for 360 degree, which positions the first and second jaws atany desirable orientation.

Moreover, in a further embodiment a tie advancing mechanism can disposedwithin the elongated shaft. With this configuration, one or morezip-ties are placed in the elongated shaft 510′, and the tie advancingmechanism is adapted to advance the zip-ties into the grooves in theopened jaws 520′ and 540′. Alternatively, one or more zip-ties areplaced partially in the shaft and partially in the first jaw, and thetie advancing mechanism is adapted to advance the zip-ties from thefirst jaw 520′ into the second jaw 540′.

In a further aspect, the present invention further provides anintra-lumenal position guide to be used together with the surgicalstring applicator described above for anastomosis surgery, which assistspositioning of the zip-ties and guiding the circular stapler used in thesurgery. Referring now to FIGS. 30-33, in one embodiment the presentinvention provides an intra-rectal guide 600 for colorectal anastomosissurgery. As shown in FIGS. 30 and 31, intra-rectal guide 600 includes aguide section 610 having a distal end 614 connected to a lead member640, and a proximal end 616 detachably connected to a proximal handlemember 660. The lead member 640, guide section 610 and proximal handlemember 660 are coaxial.

Lead member 640 has a conical front end 642 and a rear surface 644connected to guide section 610. Preferably, rear surface 644 isinclined, forming a convex rear surface; however, rear surface 644 canalso be planar. Handle member 660 includes a front cylindrical section662 with a front surface 664 detachably connected to guide section 610and a circumferentially inclined section connecting to circular shaft668 that has a substantially smaller diameter than the front cylindricalsection 662. Preferably, front surface 664 is also inclined, forming aconvex front surface; however, the front surface can also be planar. Inone exemplary embodiment, the slope of the inclined rear surface 644 oflead member 640 and the inclined front surface 664 of handle member 660is same, which forms a tapered entrance for the jaws of a surgicalstring applicator described above to enclose around the guide section610. Both lead member 640 and proximal handle member 660 have smoothouter surfaces which are in direct contact with the tissue when theguide is used. Lead member 640 and proximal handle member 660 may have asame outer diameter.

Guide section 610 has a length between lead member 640 and handle member660 equivalent or greater than the width of the jaws of the surgicalstring applicator described above, which permits closing the jaws of asurgical string applicator around guide section 610. The length of guidesection 610 can be typically from about 5 mm to about 30 mm; however, itmay vary depend on the width of the jaws of the surgical stringapplicator. The guide section has a diameter less than the diameter ofthe inner loop formed by closed jaws of a surgical string applicator, asthe zip-ties are fastened around the guide section as describedhereinafter. As an intra-rectal guide, guide section 610 has a diametergreater than the center rod of circular staplers used in colorectalanastomosis surgery. In one exemplary embodiment, guide section 610 hasa diameter from about 13 mm to about 17 mm. Moreover, as an intra-rectalguide lead member 640 and proximal handle member 660 can typically havean outer diameter from about 20 mm to about 33 mm, preferably from about28 mm to about 31 mm. The lead member 640 of an intra-rectal guide mayhave a length from about 16 mm to about 24 mm. The circular shaft 668 ofthe handle member may have an extendable length, which may be adjustedaccording to the distance of the dissecting site from the anus. As canbe appreciated, the above dimensions are given as an example inreference to an intra-rectal guide, and for a smaller tubular organ thecorresponding dimensions may be smaller or different.

The guide section 610 includes a cylindrical body 612. In the exemplaryembodiment shown, there are multiple parallel grooves 620 (620 a-620 c)disposed circumferentially around the cylindrical body. As shown inFIGS. 31 and 31A, each of the grooves has tapered side walls 622 and abottom 624. The bottom 624 of groove 620 is preferably planar forseating a zip-tie and has a width equal or greater than the width of azip-tie to be applied by the surgical string applicator. Preferably,groove 620 has a depth greater than the thickness of a zip-tie, and thecrest 626 a of ridge 626 between two adjacent grooves has a narrowwidth, which is substantially less than the width of a zip-tie. In thespecific embodiment shown, the distance between grooves 620 a and 620 c,between the closest points at the bottoms as shown by the broken linesin FIG. 31A, corresponds to the cut-distance between the grooves in thejaws of the surgical string applicator. As such, when intra-rectal guide600 is used together with a surgical string applicator, cylindrical body612 is cut at groove 620 b. It should be understood that in addition tothe grooved structure described above, the cylindrical body may haveother suitable surface structures. In one alternative embodiment, thecylindrical body has only two grooves 620 a and 620 c, without thecenter groove 620 b. In another alternative embodiment, the cylindricalbody has a micro-textured or rough surface without above describedgrooves. Instead of fixed grooves, micro-textured surface can alsoprevent slipping of the tubular organ.

As further shown in FIG. 31, cylindrical body 612 has a connectioninterface 611 at its proximal end 616, which is adapted to insert andlock into a releasable locking mechanism disposed about the center offront surface 664 of handle member 660. The handle member 660 can bedetached from cylindrical body 612 using the releasable lockingmechanism, during a surgical procedure as described hereinafter. Variousreleasable mechanical interlocking mechanisms can be used between theguide section and the handle member for the purpose of the presentinvention. In an exemplary embodiment shown, a quick lock is used, whichlocks the connection interface 611 automatically when it is inserted andreleases the connection interface by a control mechanism in the shaft668.

The lead member 640 and handle member 660 can be made of metal,silicone, plastics, or other rigid materials suitable for surgical use.The cylindrical body 612 of the guide section can be made of a rigidmaterial such as polymeric foam board that can be cut and pierced.Alternatively, the cylindrical body may include two layers. The outershell, including the grooves, can be made of a rigid material that canbe cut, and the center can be made of a soft material that can bepierced by the center rod of a circular stapler.

The use of the intra-lumenal position guide together with the surgicalstring applicator in a zip-tied anastomosis surgery described above isillustrated now in reference to a colorectal anastomosis surgery withintra-rectal guide 600 and surgical string applicator 200. In thesurgical procedure, intra-rectal guide 600 is first inserted into therectum through the anus with guide section 610 positioned at the planneddissecting site. Then, opened jaws of surgical string applicator 200 areplaced in the space between lead member 640 and handle member 660 ofintra-rectal guide 600, and are then completely closed around the rectumwith the guide section 610 inside. At this time, the handle member 660is released from guide section 610, and retrieved from the anus. Then,the tightening mechanism of the surgical string applicator is actuatedto fasten the two zip-ties placed in the grooves of the jaws. When thezip-ties are being tightened around the rectum, they are fastened intothe grooves 620 a and 620 c of intra-rectal guide 600. The two ridgesbetween these two grooves maintain the cut-distance between the twoparallel zip-ties. Then, the blade in the surgical string applicator istriggered to cut through the tissue and cylindrical body 612 at thecenter groove 620 b between the two fastened zip-ties.

After the cut, the front portion 612 a of cylindrical body 612 and leadmember 640 are sealed inside the divided colon. The divided colon istaken away from the dissecting site to remove tumor or otherabnormalities. As described above in the zip-tied colorectal anastomosissurgery, after removal of the abnormal segment, the anvil of a circularstapler is placed into the resected end of the colon and the resectedend is closed again by a zip-tie, as shown in FIGS. 5 and 17.

On the other side, a rear portion 612 b of cylindrical body 612 issealed inside the divided rectum portion. When removal of abnormalsegment is complete and the resected end is closed again by a zip-tie asdescribed above, the head member of the circular stapler is insertedinto the rectum through the anus, and placed against the rear portion612 b of cylindrical body 612 of the intra-rectal guide. As illustratedin FIG. 32, the center rod 56 of the circular stapler 50 is advanced,which perforates the rear portion 612 b and extends out from thezip-tied rectum 20. Then, the anvil shaft 66 and the center rod 56 arejoined and pulled together, as illustrated in FIG. 33. As shown, therear portion 612 b of cylindrical body 612 is around the center rod 56,which does not obstruct the staples disposed along the periphery ofcartridge 54. Therefore, the front end 58 of cartridge 54 of circularstapler 50 is pulled against anvil 60, and the stapler is actuated tostaple the colon 30 and the rectum 20 together as described above.

As can be appreciated, the method of using the intra-rectal guidetogether with the surgical string applicator in the colorectalanastomosis surgery has several advantages. Using the intra-rectalguide, the zip-ties are fastened within the grooves in the guidesection, and the grooves prevent any lateral movement of the zip-ties onthe slippery tissue. On the other hand, the cylindrical body of theintra-rectal guide creates a central guide within the zip-tied tissue,which directs a central positioning of the center rod of the circularstapler. As such, when the center rod of the circular stapler perforatesthe cylindrical body, it assures the desired central alignment betweenthe zip-tied rectum and the zip-tied colon. Therefore, with theassistance of the intra-rectal guide, quality and safety of the zip-tiedanastomosis surgery method can be further improved.

While there has been shown and described the preferred embodiment of theinstant invention it is to be appreciated that the invention may beembodied otherwise than is herein specifically shown and described andthat, within said embodiment, certain changes may be made in the formand arrangement of the parts without departing from the underlying ideasor principles of this invention as set forth in the Claims appendedherewith.

What is claimed is:
 1. A surgical string applicator for anastomosissurgery comprising: an elongate shaft having a proximal and distal end;a string applying assembly comprising a first and a second opposing jawconnected to said distal end of said elongate shaft and configured toclose around a tubular organ of the anastomosis surgery, at least onejaw having one or more grooves along an inner surface of the at leastone jaw, and each of said jaws having an opening at a distal endthereof; at least one surgical string housed in the first and secondjaws in a form of an open loop with one end of the surgical string atthe distal end of the second jaw and an opposing end of the surgicalstring at the distal end of the first jaw; and a string fasteningmechanism adapted to engage and fasten said surgical string around thetubular organ, wherein said string fastening mechanism comprises a tiegripping member disposed within the first jaw configured to grip saidone end of the surgical string extended into the opening of the firstjaw from the second jaw when said jaws are closed around the tubularorgan such that the surgical string encircles the tubular organ, and thestring fastening mechanism is configured to tighten the at least onesurgical string around the tubular organ; and a handle portion connectedto said proximal end of said elongate shaft; said handle portionincluding one or more triggers configured to open and close at least oneof said jaws, and to actuate said string fastening mechanism.
 2. Thesurgical string applicator of claim 1, wherein proximal ends of saidfirst and second jaws are connected to said distal end of said elongateshaft, and at least one of said jaws pivots at said proximal end of thejaws.
 3. The surgical string applicator of claim 1, wherein said jawsarticulate relative to, and rotate about, a longitudinal axis of saidelongate shaft.
 4. The surgical string applicator of claim 1, whereinsaid string fastening mechanism is configured to drive said tie grippingmember along a portion of the first jaw.
 5. The surgical stringapplicator of claim 1, wherein said string fastening mechanism isconfigured to tighten the tubular organ to the distal ends of the jaws.6. The surgical string applicator of claim 1, wherein opposing ends ofsaid jaws are so configured that when said jaws move from an openposition to a closed position, said one end of said surgical stringdisposed at the distal end of the second jaw is caused to enter intosaid opening at the distal end of the first jaw.
 7. The surgical stringapplicator of claim 1, wherein said string applying assembly isconfigured to advance said one end of said surgical string for enteringinto said opening at the distal end of the first jaw.
 8. The surgicalstring applicator of claim 1, wherein at least one of said jaws includestwo of said grooves parallel with each other and with a predetermineddistance therebetween.
 9. The surgical string applicator of claim 8comprising two surgical strings, each disposed within a respective oneof said grooves with said one end of each surgical string disposed inthe distal end of the second jaw and the opposing end of each surgicalstring disposed in the distal end of the first jaw.
 10. The surgicalstring applicator of claim 1, wherein the surgical string applicator isconfigured to dissect tissue fastened by said surgical string.
 11. Thesurgical string applicator of claim 1, wherein the string fasteningmechanism is configured to pull said tie gripping member gripped on saidone end of the surgical string from the distal end of the first jawtoward the proximal end of the first jaw to tighten the surgical stringaround the tubular organ.
 12. A surgical string applicator system foranastomosis surgery comprising the surgical string applicator of claim 1and an intra-lumenal position guide, said intra-lumenal position guidecomprising a guide section having a distal end connected to a leadmember and a proximal end detachably connected to a proximal handlemember; said guide section including multiple parallel grooves disposedcircumferentially.
 13. The surgical string applicator system of claim12, wherein at least one of the jaws of the surgical string applicatorhas two grooves with a predetermined distance therebetween, and adistance between the parallel grooves on the guide section of theintra-lumenal position guide corresponds to the predetermined distancebetween the two grooves in the jaws of the surgical string applicatorfor applying the surgical string in the parallel grooves on the guidesection of the intra-lumenal position guide inserted into the tubularorgan.
 14. The surgical string applicator system of claim 13, whereinthe surgical string applicator comprises two surgical strings, eachdisposed within a respective one of said grooves with said one end ofeach surgical string disposed in the distal end of the second jaw andthe opposing end of each surgical string disposed in the distal end ofthe first jaw.
 15. The surgical string applicator system of claim 12,wherein the guide section has a length between the lead member and theproximal handle member equivalent to or greater than a width of the jawsof the surgical string applicator for closing the jaws around the guidesection.